: Comparison the effect of ovarian PRP with and without vaginal RF on the number of oocyte and embryos in patients with diminished ovarian reserve and candidates for IVF
Comparative study of the effect of ovarian platelet-Rich plasma with and without vaginal Radiofrequency on the number of eggs and embryos in people with reduced ovarian reserve and InVitroFertilization candidates
Design
Phase 3 randomized, parallel-group, controlled clinical trial on 60 patients using G*power software
Settings and conduct
Study population: Patients will be divided into two groups, the intervention group includes people who undergo vaginal RF in addition to ovarian PRP, and the second group will undergo ovarian PRP without vaginal RF. Individuals from the research team who are involved in random assignment and intervention will not be involved in examining the study outcomes (dependent variables). The study location is Nikan Hospital, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having decreased ovarian reserve based on the definition of "antral follicle count or AFC less than 5 to 7 follicles and AMH level less than 1.1 ng/ml who referred due to infertility. Normal vaginal endo-cytology without any evidence of malignancy with atypia. Non-entry criteria: receiving hormone replacement in the past six months, having a pacemaker or any metal device in the pelvic area.
Intervention groups
The intervention group consists of patients with diminished ovarian reserve who receive PRP with vaginal radiofrequency intervention. The comparison group consists of patients with diminished ovarian reserve who receive PRP only.
Main outcome variables
1) number of oocytes retrieved and 2) number of fetuses transferred, 3) any unwanted side effects during treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N15
Registration date:2025-08-26, 1404/06/04
Registration timing:registered_while_recruiting
Last update:2025-08-26, 1404/06/04
Update count:0
Registration date
2025-08-26, 1404/06/04
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-08-03, 1404/05/12
Expected recruitment end date
2028-03-20, 1407/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Comparison the effect of ovarian PRP with and without vaginal RF on the number of oocyte and embryos in patients with diminished ovarian reserve and candidates for IVF
Public title
Studying the effectiveness of vaginal radiofrequency on ovarian reserve in people with reduced ovarian reserve
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having diminished ovarian reserve as defined by an antral follicle count or AFC of less than 5 to 7 follicles and an AMH level of less than 1.1 ng/ml who presented for infertility. Normal vaginal endocytology without any evidence of malignancy with atypia.
Not receiving hormone replacement therapy for six months,
no pacemaker or any metal device in the pelvic area.
Exclusion criteria:
For any reason, the patient is unwilling to participate in the study.
Age
From 25 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of individuals to the intervention and control groups will be done as described using cards placed inside Sequentially Numbered Sealed Opaque Envelopes (SNOSE). These cards will be prepared in the same number as the intervention and control groups (e.g., cards numbered one for the intervention group and numbered two for the control group) and will be placed inside the sealed opaque envelopes. After shuffling the envelopes, each person meeting the inclusion criteria will select an envelope to determine their study group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Individuals from the research team who are involved in the random assignment and intervention ( PRP with and without vaginal radioferquency) will not be involved in examining the study outcomes (dependent variables).
Placebo
Not used
Assignment
Parallel
Other design features
The present study is the first to evaluate the effect of ovarian PRP with and without vaginal RF on the number of eggs and embryos in individuals with DOR and candidates for IVF.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences ethics committee
Intervention group:The intervention group includes people who undergo vaginal RF in addition to ovarian PRP. First, patients enter an IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in such a way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained in both groups is recorded. Then, in the intervention group, they undergo vaginal RF in 4 sessions over a period of 2 months. In these patients, RF is performed in the form of capacitive electrical transmission, in a monopolar configuration, which has two electrodes, one placed in the vaginal area and the other in the lumbosacral area. Participants are placed in the supine position. The temperature will be set to 45 degrees Celsius, with a frequency of 1 MHz and a power of 80 kilojoules. Once the desired temperature is reached, the interventional researcher holds it in a semicircular motion on the lateral walls of the vagina for 30 minutes. Each patient will undergo RF treatment for 4 sessions at 2-week intervals over 2 months. Both groups will be re-entered into the IVF cycle and the number of oocytes and embryos retrieved will be recorded. Finally, the average number of oocytes and embryos in both groups before and after vaginal RF is compared. After the treatment period, patients will be evaluated for the following outcomes: 1) number of oocytes retrieved and 2) number of embryos retrieved, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied.
Category
Treatment - Devices
2
Description
Control group: In the control group, ovarian PRP is performed without vaginal RF. In this way, patients enter the IVF cycle with a fixed protocol, and simultaneously with ovarian puncture and egg extraction, ovarian PRP is performed in this way that a sample is prepared from the individual's peripheral blood and blood platelets are extracted 4-5 times and injected in an amount of 1.5 cc into each ovary. The number of eggs and embryos obtained is recorded. In this group, the vaginal RF maneuver is also performed every 2 weeks, but in a simulated manner and without turning on the device. Then, both groups are entered into the IVF cycle again, and the number of eggs and embryos obtained is recorded. Finally, the average number of eggs and embryos in both groups before and after vaginal RF is compared with each other. After the treatment period, patients are evaluated for the following outcomes: 1) number of oocytes retrieved, 2) number of embryos obtained, 3) any unwanted treatment complications during treatment, and 4) patient satisfaction level with the treatment protocol on a five-level scale of completely dissatisfied, somewhat dissatisfied, no opinion, somewhat satisfied, and completely satisfied.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikan Hospital
Full name of responsible person
Leila Nazari
Street address
Tajrish street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 912 316 4282
Email
nazari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mrs Bakhtiari
Street address
velenjak
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 936 068 8094
Email
nazari@sbmu.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 912 316 4282
Email
nazari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
leila nazari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 912 316 4282
Email
nazari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sanira yavari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
tajrish
City
tehran
Province
Tehran
Postal code
1234567890
Phone
+98 912 765 5905
Email
s.yavari@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available